Pilot Study to Evaluate Immunopotentiating Effects of Immulina in Elderly Individuals
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Interferon gamma (IFNg)
Study Overview
Brief Summary
This will be a small study aimed at determining the effects of oral Immulina consumption on the immune system in elderly individuals.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age 60 and older;
- •Generally otherwise healthy for age and not taking medications/supplements that could be expected to affect stress responses and/or impact immune parameters (example - systemic steroids, beta blockers, antidepressants, anti-anxiety drugs, Echinacea supplements, ginseng supplements or Spirulina supplements).
Exclusion Criteria
- •Inability to comprehend and speak English;
- •Any history of major psychological or psychiatric illness (example - dementia, psychotic disorder, acute mania, current substance abuse) that may limit participant cooperation or compromise the integrity of self-reported clinical or psychological data;
- •Presence of a confounding underlying systemic illness which could interfere with immunological profiles (example - severe cardiovascular, pulmonary, hepatic, gastrointestinal, renal, neurological, musculoskeletal endocrine , or metabolic systems; other gross physical impairments; or any history of significant convulsive disorder). Specifically, patients with congestive heart failure, recent viral or bacterial illness in the past 3 weeks, chronic kidney disease, thyroid disorder, autoimmune disease will be excluded.
Arms & Interventions
Placebo
10 participants will be randomized to take 1 capsule of placebo daily.
Intervention: Immulina (Dietary Supplement)
Immulina 200 mg/day
10 participants will be randomized to take 200 mg/day of Immulina.
Intervention: Immulina (Dietary Supplement)
Immulina 400 mg/day
10 participants will be randomized to take 400 mg/day of Immulina.
Intervention: Immulina (Dietary Supplement)
Immulina 800 mg/day
10 participants will be randomized to take 800 mg/day of Immulina.
Intervention: Immulina (Dietary Supplement)
Outcomes
Primary Outcomes
Interferon gamma (IFNg)
Time Frame: 8 weeks
Increase in IFNg from baseline to 8 weeks
Secondary Outcomes
- Psychological Measures(8 weeks)
- Optimal supplement regime(8 weeks)
- Demographic differences(8 weeks)
- Immune biomarkers(8 weeks)
Investigators
Gailen D. Marshall
Professor of Medicine and Pediatrics, Vice Chair for Research, Department of Medicine, Director, Division of Clinical Immunology and Allergy, Chief, Laboratory of Behavioral Immunology Research
University of Mississippi Medical Center